NCT03054623

Brief Summary

Our study seeks to define the effect of each component of the distal revascularization interval ligation (DRIL) procedure on the in vivo distal blood pressure of patients with ischemic steal, and to determine whether the interval ligation component of the DRIL procedure is necessary or not.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2018

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

February 13, 2017

Last Update Submit

January 21, 2025

Conditions

Steal SyndromeChronic Kidney DiseasesArterio-Venous Fistula

Outcome Measures

Primary Outcomes (1)

  • Difference in forearm pressures

    one year

Secondary Outcomes (1)

  • Proportion of interval ligation procedures

    one year

Study Arms (1)

DRIL procedure

Adult (\>18 yo) patients with chronic kidney disease with functioning antecubital-based arteriovenous fistulae and evidence of ischemic steal symptoms

Procedure: DRIL procedure

Interventions

DRIL procedurePROCEDURE

The DRIL procedure involves creation of a bypass from an arterial inflow site (usually mid brachial artery) proximal to the fistula inflow, to the bifurcation of the brachial artery distal to the fistula, with ligation of the intervening native vessel, thus restoring distal flow while preserving flow through the fistula.

DRIL procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult (\>18 yo) patients with chronic kidney disease with functioning antecubital-based arteriovenous fistulae and evidence of ischemic steal symptoms

You may qualify if:

  • \>18 yo patients with CKD with a functioning antecubital-based arteriovenous fistula and evidence of ischemic steal as defined above

You may not qualify if:

  • Patients identified as undergoing "prophylactic" or "preemptive" DRIL procedure at the time of fistula/graft creation (ie, do not have documented steal at present)
  • Patients unable to provide informed consent, life expectance of less than one year
  • Inability to reliably or accurately measure contralateral blood pressures due to heavily calcified vessels documented preoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of South Florida South Tampa Campus

Tampa, Florida, 33606, United States

Location

Related Publications (5)

  • Zanow J, Krueger U, Reddemann P, Scholz H. Experimental study of hemodynamics in procedures to treat access-related ischemia. J Vasc Surg. 2008 Dec;48(6):1559-65. doi: 10.1016/j.jvs.2008.06.040. Epub 2008 Sep 4.

    PMID: 18771888BACKGROUND

  • Aimaq R, Katz SG. Using distal revascularization with interval ligation as the primary treatment of hand ischemia after dialysis access creation. J Vasc Surg. 2013 Apr;57(4):1073-8; discussion 1078. doi: 10.1016/j.jvs.2012.10.085. Epub 2013 Jan 29.

    PMID: 23375137BACKGROUND

  • Leake AE, Winger DG, Leers SA, Gupta N, Dillavou ED. Management and outcomes of dialysis access-associated steal syndrome. J Vasc Surg. 2015 Mar;61(3):754-60. doi: 10.1016/j.jvs.2014.10.038. Epub 2014 Dec 9.

    PMID: 25499703BACKGROUND

  • Illig KA, Surowiec S, Shortell CK, Davies MG, Rhodes JM, Green RM. Hemodynamics of distal revascularization-interval ligation. Ann Vasc Surg. 2005 Mar;19(2):199-207. doi: 10.1007/s10016-004-0162-y.

    PMID: 15770367RESULT

  • Varble N, Day S, Phillips D, Mix D, Schwarz K, Illig KA, Chandra A. In vitro hemodynamic model of the arm arteriovenous circulation to study hemodynamics of native arteriovenous fistula and the distal revascularization and interval ligation procedure. J Vasc Surg. 2014 May;59(5):1410-7. doi: 10.1016/j.jvs.2013.04.055. Epub 2013 Jul 9.

    PMID: 23845661RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicArteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Study Officials

  • Karl Illig, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

September 20, 2016

Primary Completion

August 11, 2018

Study Completion

August 11, 2018

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)